Otc - Active Ingredient
Tolnaftate 1%
Initial Treatonic Fungal Nail Renewal Patches Patch
FDA Label NDC 85569-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 100 Karma Inc for the product Initial Treatonic Fungal Nail Renewal Patches (NDC 85569-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - do not use, otc - when using, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Dosage & Administration
- Helps inhibit the growth of fungus.
- Improves the appearance of nails affected by fungus,including discoloration, thickening, splitting, crumbing, and brittleness.
Warnings
For external use only
Otc - Do Not Use
- on children under 2years of age unless directed lby a doctor
- on dliaper rash
Otc - When Using
Avoid contact with eyes. do not exceed the recommended daily dosage unless directed by a doctor.
Otc - Ask Doctor/Pharmacist
- iritation occurs
- there is no improvement within 4 weeks.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Indications & Usage
- Clean & prepare the affected nail,
- Applythe antifungal solution to the affected nail.
- Apply the fungus nail patch, Fimly secure the patch to the sides of the toes or fingers,folding the remaining achesive partto fully cover the toes/fingertips.
- Leave the patch on for 6-8 hours.Frequency. Use the patches consistently before bed.
- Maintain good foothygiene.
Other Safety Information
store at 20-25°C(68-77°F)
Inactive Ingredient
Water, Glycerin, Sodium Carboxymethyl Cellulose,Butylene Glycol, Urea
Otc - Questions
Email: [email protected]
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